ABM-1310 / ABM Therap - LARVOL DELTA

A phase I study for safety, tolerability, pharmacokinetics, and anti-tumor activity of ABM-1310 in patients (pts) with BRAF V600 mutation-positive solid tumors: The final result (ESMO-TAT 2025) - P1 | "ABM-1310 was generally well tolerated without unknown safety concerns. ABM-1310 monotherapy's anti-tumor activity was clearly observed in pts with BRAF V600 mutation-positive solid tumors, especially in pts with NSCLC and CRC."

Clinical • P1 data • PK/PD data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF

A Study of ABM-1310 in Patients With BRAF V600-Mutant Relapsed and Drug Resistant Primary Malignant Brain Tumors (clinicaltrials.gov) - P1 | N=15 | Terminated | Sponsor: ABM Therapeutics Shanghai Company Limited | N=52 ➔ 15 | Trial completion date: May 2028 ➔ Aug 2024 | Recruiting ➔ Terminated | Trial primary completion date: May 2028 ➔ Aug 2024; Adjustment of the applicant's research and development strategy

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Brain Cancer • Oncology • Solid Tumor • BRAF

A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=20 | Terminated | Sponsor: ABM Therapeutics Shanghai Company Limited | N=72 ➔ 20 | Trial completion date: Aug 2025 ➔ Jun 2024 | Recruiting ➔ Terminated | Trial primary completion date: Aug 2025 ➔ Jun 2024; Adjustment of the applicant's research and development strategy

Enrollment change • Metastases • Trial completion date • Trial primary completion date • Trial termination • Oncology • Solid Tumor • BRAF

A phase 1 open-label study of BRAF inhibitor ABM-1310 in patients (pts) with recurrent BRAF V600-mutated primary CNS tumors (SNO 2024) - No abstract available

Clinical • P1 data • Brain Cancer • CNS Tumor • Oncology

A phase I study for safety, tolerability, pharmacokinetics, and anti-tumor activity of ABM-1310 in patients (pts) with BRAF V600 mutated recurrent primary brain tumours: Interim result (ESMO 2024) - P1 | "ABM-1310 was generally tolerated without unknown safety signals. Preliminary anti-tumor activity was observed in pts with BRAF V600-mutated recurrent primary brain tumors."

Clinical • P1 data • PK/PD data • Astrocytoma • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • BRAF

Interim analysis of ABM-1310, a blood-brain barrier-penetrant BRAF inhibitor, in patients with BRAF V600-mutated solid tumors. (ASCO 2024) - P1 | "ABM-1310, either alone or in combination with cobimetinib, was well tolerated without new or unexpected side effects or safety issues. Preliminary efficacy of ABM-1310 was seen in pts with BRAF V600-mutated solid tumors, including those who were refractory to prior BRAF ± MEK inhibitors."

Clinical • Astrocytoma • Brain Cancer • CNS Tumor • Dermatology • Endocrine Cancer • Gastrointestinal Cancer • Glioblastoma • Hematological Disorders • Hepatology • Melanoma • Musculoskeletal Pain • Neutropenia • Oncology • Pain • Pancreatic Cancer • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=53 | Terminated | Sponsor: ABM Therapeutics Corporation | N=112 ➔ 53 | Trial completion date: Jan 2025 ➔ Apr 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Sep 2024 ➔ Apr 2024; Not related to safety concerns or lack of efficacy

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Brain Cancer • Oncology • Solid Tumor • BRAF

Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=112 | Active, not recruiting | Sponsor: ABM Therapeutics Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Brain Cancer • Oncology • Solid Tumor • BRAF

ABM Therapeutics' ABM-1310 Granted Fast Track Designation by the FDA Following Orphan Drug Designation (PRNewswire) - "ABM Therapeutics is pleased to announce today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of ABM-1310 for the treatment of Glioblastoma (GBM) patients carrying BRAF V600E mutation, following the Orphan Drug Designation for ABM-1310 to treat malignant gliomas including GBM received in July."

Fast track designation • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

ABM Therapeutics' ABM-1310 Granted Fast Track Designation by the FDA Following Orphan Drug Designation (PRNewswire) - "ABM Therapeutics is pleased to announce today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the investigation of ABM-1310 for the treatment of Glioblastoma (GBM) patients carrying BRAF V600E mutation, following the Orphan Drug Designation for ABM-1310 to treat malignant gliomas including GBM received in July....ABM-1310 is an investigational therapeutic candidate currently undergoing clinical development for BRAF V600E mutant solid tumors."

Fast track designation • Glioblastoma

ABM Therapeutics Announces First Patient Dosed in Phase I Study of ABM-1310 in patients with BRAF V600 in Relapsed and Drug Resistant Primary Malignant Brain Tumors (Canada Newswire) - "ABM Therapeutics...today announced that the first patient has been successfully dosed in its multicenter Phase I study of ABM-1310 in patients with relapsed and drug resistant primary malignant brain tumors in China. This is the second clinical study of ABM-1310 in China."

Trial status • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

U.S. FDA Grants Orphan Drug Designation to ABM-1310 for the Treatment of Patients with Glioblastoma Harboring BRAF V600 Mutation (PRNewswire) - "ABM Therapeutics (ABM) announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310, a novel small molecule BRAF inhibitor developed by the company, for the treatment of patients with glioblastoma (GBM) bearing BRAF V600 mutation....ABM-1310 is an orally administered medicine with high BRAF-mutation selectivity, high water solubility, and high blood-brain barrier permeability."

Orphan drug • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor • BRAF

A Study of ABM-1310 in Patients With BRAF V600-Mutant Relapsed and Drug Resistant Primary Malignant Brain Tumors (clinicaltrials.gov) - P1 | N=52 | Recruiting | Sponsor: ABM Therapeutics Shanghai Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Brain Cancer • Oncology • Solid Tumor • BRAF

A phase 1, multicenter, open-label study of a new BRAF inhibitor ABM-1310 in adult patients (pts) with BRAFv600-mutated solid tumors. (ASCO 2023) - P1 | "ABM-1310 at the currently tested doses up to 200 mg bid, either alone or in combination with cobimetinib, was generally well tolerated, with no new safety signals. Preliminary efficacy data demonstrate favorable activity of ABM-1310 in pts with BRAFv600-mutated solid tumors, including primary CNS tumors, and pts previously refractory to other BRAF/MEK inhibitors and I/O therapies. Clinical trial information: NCT04190628."

Clinical • P1 data • Astrocytoma • Brain Cancer • CNS Tumor • Dermatology • Glioblastoma • Melanoma • Oncology • Solid Tumor

A Study of ABM-1310 in Patients With BRAF V600-Mutant Relapsed and Drug Resistant Primary Malignant Brain Tumors (clinicaltrials.gov) - P1 | N=52 | Not yet recruiting | Sponsor: ABM Therapeutics Shanghai Company Limited

New P1 trial • Brain Cancer • Oncology • Solid Tumor • BRAF

ABM Announces First Patient Dosed in Phase I Clinical Trial of MEK Inhibitor for Solid Tumor (PRNewswire) - "ABM Therapeutics...today announced that the first patient was successfully dosed with ABM-168 in the United States....This phase I clinical trial in the US is a first-in-human multicenter, open-label, dose escalation and cohort expansion study, which is intended to assess the safety, tolerability, and pharmacokinetics of ABM-168 monotherapy in adult patients with advanced/metastatic solid tumors."

Trial status • Oncology • Solid Tumor

ABM-1310 has significant improved BBB-penetration and intracranial tumor growth inhibition compared to FDA approved BRAF inhibitors (AACR 2023) - "Also, in the A375-luc intracranial model, ABM-1310 alone or combo with ABM proprietary, BBB-penetrable MEK inhibitor ABM-168, demonstrated significant improved antitumor activity and animal medial survival time (MST) compared with combination regimens of other BRAF/MEK inhibitors (vemurafenib + cobimetinib, dabrafenib + trametinib, or encorafenib + binimetinib). Either ABM-1310 as a single agent or the combination of ABM-1310 and ABM-168 showed a BLI decrease (%) > 99% on Day 26 and MST of > 69 days, while MST for vehicle was 27 days, and MST for the combo of Dabrafenib and Trametinib was 33 days. In a primary GBM model (DBTGR-05MG, a BRAFv600 mutant GBM cell line), the similar result was demonstrated."

FDA event • Brain Cancer • CNS Tumor • Colon Cancer • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor • Thyroid Gland Anaplastic Carcinoma • Thyroid Gland Carcinoma • Thyroid Gland Papillary Carcinoma

Preclinical development of ABM-168, a novel MEK Inhibitor to treat cancer with brain tumors (AACR 2023) - "In-vitro data showed the similar on-target enzyme activity of ABM-168 to marketed MEK inhibitors, as well as high anti-proliferation activities (IC50 <30nM) in multiple cancer cell lines with BRAF or RAS or NF1 mutation like A375, Colo-829, HT-29, MiaPaca-2, LN-229 etc. In vivo pharmacology studies demonstrated that ABM-168 had good potencies of tumor growth inhibitions with oral dose alone or combo with other drugs or compounds in multiple xenograft cancer models: In an A375-luc intracardiac melanoma metastatic model, ABM-168 at 2 mg/kg PO BID demonstrated an antitumor activity comparable to ABM-1310 (A highly BBB-permeable BRAF inhibitor developed by ABM Therapeutics) at different dose levels and frequencies. Single-dose, seven-day repeat dose non-GLP studies and four-week GLP toxicity studies in SD rats and beagle dogs were all completed. Based on these supportive preclinical study results, the IND of ABM-168 was submitted in 2022 Q3 to investigate its safety in..."

Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Melanoma • Oncology • Solid Tumor • NF1

Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=112 | Recruiting | Sponsor: ABM Therapeutics, Inc. | N=48 ➔ 112

Combination therapy • Enrollment change • Metastases • Monotherapy • Brain Cancer • Melanoma • Oncology • Solid Tumor • BRAF

Safety of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: ABM Therapeutics, Inc. | Trial completion date: Jun 2022 ➔ Jan 2025 | Trial primary completion date: Jun 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: ABM Therapeutics Shanghai Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • BRAF

A Study of ABM-1310 in Patients With BRAF V600-Mutant Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: ABM Therapeutics Shanghai Company Limited

New P1 trial • Oncology • Solid Tumor • BRAF

Safety of ABM-1310 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: ABM Therapeutics, Inc. | Trial completion date: Dec 2021 ➔ Jun 2022 | Trial primary completion date: Dec 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

"#ABMTherapeutics Receives #IND Approval in China for #BRAFInhibitor #ABM1310 https://t.co/mnmoMpgE0Q" (@1stOncology)

ABM Therapeutics Receives IND Approval in China for BRAF Inhibitor ABM-1310 (Canada Newswire) - "ABM Therapeutics...announced that its IND application for ABM-1310, a new-generation BRAF inhibitor, has been approved by the National Medical Products Administration (NMPA) to conduct Phase 1 clinical trials in patients of advanced solid tumors with BRAF mutation in China. This is the first clinical candidate and IND approval obtained by ABM Therapeutics in China."

New P1 trial • Oncology • Solid Tumor